Single-center, Non-randomized, Comparative, Post-marketing Surveillance Cohort Study on Validation of a Questionnaire on Quality of Life After Surgical Stabilization of the Urethra With Titanized Polypropylene Mesh (TiLOOP® Tape)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- pfm medical gmbh
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Validation of a new questionnaire on quality of life
Study Overview
Brief Summary
Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra.
Detailed Description
The prevalence of urinary incontinence in the adult female population has been estimated between 10% and 40%. Several treatment alternatives have been suggested until now. Nevertheless, the ideal treatment has not been identified yet. On the one hand this is related to the low amount of valid scientific information regarding different treatment methods. On the other hand the impact of patients' quality of life, which plays a major role, has not been fully considered. To date, there is no established Questionnaire on Quality of Life that provides physicians an assistance to obtain information on the subjective effects caused by stress urinary incontinence.
In the present study the patients' Quality of Life will be assessed by use of two questionnaires, that is a new one and an already validated questionnaire. The study population consists of patients who already received an implantation of a sub-urethral surgical mesh (TiLOOP® Tape), of symptomatic patients before an operation, and of a group of non-symptomatic women. Subjects will be asked in a single visit only to fill in both questionnaires.
Furthermore the safety and effectiveness of the TiLOOP® Tape mesh will be evaluated in the study arm of treated patients.
Study has been terminated after major recruitment failure (only 21 instead of 240 patients has been included).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Depending on study arm:
- •Women with a TiLOOP® Tape implant, Implanted between 2007 and 2009 at the study center - OR -
- •Woman with a planned Tape implantation at the study center - OR -
- •Woman with no disease related to incontinence
- •Subject is able to understand the nature, relevance and significance of the clinical trial
- •Subject has given informed consent
Exclusion Criteria
- •Subject revoked consent
- •Lack of subject's compliance regarding data collection or examination in the scope of the trial (Non-Compliance)
- •Subject institutionalized by court or official order (MPG §20.3)
- •Subject participates in another clinical investigation
Outcomes
Primary Outcomes
Validation of a new questionnaire on quality of life
Time Frame: before treatment (baseline) or 6 to 24 months after treatment, respectively
It is expected that the newly developed questionnaire on quality of life (QoL) is equal or better in description of the impact on QoL regarding the differentiation of the study populations, as compared to the standard questionnaire.
Secondary Outcomes
- Safety of surgical mesh implantation for treatment of urinary incontinence(6-24 months after treatment)
- Effectiveness of surgical mesh implantation for treatment of urinary incontinence(6-24 months after treatment)